Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2026-01-26 @ 11:41 AM
Study NCT ID:
NCT02485106
Status:
UNKNOWN
Last Update Posted:
2015-06-30
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rifaximin Use in Severe Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'lastUpdateSubmitDate': '2015-06-25', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6-month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Alcoholic Hepatitis']}, 'referencesModule': {'references': [{'pmid': '39662593', 'type': 'DERIVED', 'citation': 'Song DS, Yang JM, Jung YK, Yim HJ, Kim HY, Kim CW, Kim SS, Cheong JY, Lee HL, Lee SW, Yoo JJ, Kim SG, Kim YS. Rifaximin treatment in patients with severe alcohol-associated hepatitis: A multicenter, randomized controlled, open-label, pilot trial. Ann Hepatol. 2025 Jan-Jun;30(1):101749. doi: 10.1016/j.aohep.2024.101749. Epub 2024 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Heavy alcohol drinking within 3 months (Over 40 g/day)\n* Maddrey's discriminant function ≥ 32\n* AST/ALT ration ≥ 2\n* Bilirubin level ≥ 5mg/dL\n* Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis\n* Age : 19-75\n* Jaundice within 3 months\n\nExclusion Criteria:\n\n* Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis)\n* Antibiotics or probiotics use within 8 weeks\n* Drug induced hepatotoxicity\n* Acute viral hepatitis (HAV or HEV)\n* Hepatic abscess or cholagitis\n* Hepatocellular carcinoma of modified UICC stage II, III or IV\n* Malignant tumor other than HCC\n* Pregnancy\n* Severe chronic extrahepatic disease\n* Type I hepatorenal syndrome\n* Hepatic encephalopathy grade II or IV\n* Severe infection"}, 'identificationModule': {'nctId': 'NCT02485106', 'briefTitle': 'Rifaximin Use in Severe Alcoholic Hepatitis', 'organization': {'class': 'OTHER', 'fullName': "Saint Vincent's Hospital, Korea"}, 'officialTitle': 'Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis', 'orgStudyIdInfo': {'id': 'SDS-SAH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rifaximin group', 'description': 'Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days', 'interventionNames': ['Drug: Rifaximin', 'Drug: Corticosteroid or pentoxifylline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Corticosteroid or Pentoxifylline for 28 days', 'interventionNames': ['Drug: Corticosteroid or pentoxifylline']}], 'interventions': [{'name': 'Rifaximin', 'type': 'DRUG', 'description': '400mg three times per day for 28 days', 'armGroupLabels': ['Rifaximin group']}, {'name': 'Corticosteroid or pentoxifylline', 'type': 'DRUG', 'description': 'Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days', 'armGroupLabels': ['Control group', 'Rifaximin group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Do Seon Song', 'role': 'CONTACT', 'email': 'dsman@catholic.ac.kr', 'phone': '82-31-249-8204'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint Vincent's Hospital, Korea", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'Do Seon Song', 'investigatorAffiliation': "Saint Vincent's Hospital, Korea"}}}}